CMC Conversations in Latin America Session III
November 7, 2023
Post-approval changes (PAC) to the registered information of authorized medicinal products are routinely introduced worldwide, and their review represents a significant and increasing workload for regulators. Moreover, handling many different types of dossiers for the same product and managing change implementation worldwide is burdensome for industry. In Latin America, the diversity of CMC requirements and reporting change categories, regulatory gaps, and distinct procedures for PAC continue to represent a challenge, with potential impact on the availability of medicinal products in the region.
The first edition of the 2023 CMC Conversations in Latin America will be a virtual interactive session, gathering regulators and industry - from the region and beyond - to explore solutions in optimizing the submission, review and implementation process of CMC variations, focusing on convergence with international standards and adoption of best practices.
Session I - Tuesday, 6 June 2023
Why Optimize the Submission and Review of CMC Post-Approval Changes? Global Trends and Challenges for Latin America
Session II - Tuesday, 19 September 2023
Pathway to Optimizing Submission and Review of CMC Post-Approval Changes: Employing Scientific Risk-Based Principles, Reliance Pathways, Adoption of WHO Post-Approval Guidelines, and Collaborative Assessments
Session III - Tuesday, 7 November 2023
One Single Dossier for Global Submissions: The Role of Regulatory Convergence and Harmonization to Improve Efficiency and Reduce the Regulatory Burden of CMC Post-Approval Changes